The effect of 0,9% SodiumChloride on the kidney function, vaso-active hormones, biomarkers and glycocalyx in patients operated on for primary hiparthrosis.

The effect of 0,9% NaCl on the kidney function, vasoactive hormones, biomarkers and glycosaminglycanes in plasma in patients operated on for primary hiparthrosis. - 0,9% NaCl effect on kidney function and glycocalyx in patients operated on for primary hiparthrosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-004742-10-DK

Enrollment

Unknown

Registered

2014-11-12

Start date

2014-12-17

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney function during operation MedDRA version: 18.0 Level: LLT Classification code 10023422 Term: Kidney function abnormal System Organ Class: 100000004857

Interventions

Trade Name: Isoton NaCl Pharmaceutical Form: Infusion Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use Trade Name: Plasmalyte Product Name: Plasmal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Alder > 18 year Indication for ucementeret primary hiparthroplasty Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: Blooddonation or transfusion during the last month Not willing to participate estimated GFR below 30ml/min type 1 diabetes

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate how isoton SodiumChloride effect kidney function, vaso-active hormones, and the Glycocalyxlayer;Secondary Objective: Not applicable;Primary end point(s): Kidney function - Neutrophil gelatinase associated lipocalin (NGAL);Timepoint(s) of evaluation of this end point: Before-during and after operation	—

Secondary

Measure	Time frame
Secondary end point(s): p-Syndecan-1, PRC, p-Ang-II, p-Aldo, p-ANP, p-BNP, p-AVP, CH2O, p-alb, p-Cl, p-endot, p-cGMP, p-crea, p-Osm, p-Na, p-k u-KIM, u-FABP, u-cGMP, u-crea, u-K, u-Osm, FENa, u-EnaCß, u-Alb, u-AQP2, u-NCC, u-NK2CC, pH, u-Na, u-Cl, Pulse, MAP ;Timepoint(s) of evaluation of this end point: Not relevant	—

Countries

Denmark

Contacts

Public ContactNiels Peter Ekeløf

Department of Medical Research, regional Hospital Holtebro

nieeke@rm.dk004578432821

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026